Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005423 |
| Other study ID # |
4341 |
| Secondary ID |
R03HL048530 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2000 |
| Last updated |
March 15, 2016 |
| Start date |
July 1992 |
| Est. completion date |
December 1994 |
Study information
| Verified date |
April 2002 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To examine dietary quality and subsequent cardiovascular disease (CVD).
Description:
BACKGROUND:
Although considerable evidence exists for associations between diet and subsequent
cardiovascular disease (CVD) among younger and middle-aged adults, no comprehensive studies
of these relationships have been conducted using a national sample of older Americans.
National guidelines have recommended reductions of dietary fat, saturated fat, cholesterol
and sodium as dietary practice to reduce CVD. However, it is possible that the focus on
eliminating dietary components may obscure the advantages of consuming diets that are
nutritionally adequate.
Findings from this study could have important implications for setting research priorities
to further study the effects of specific dietary variables on CVD, and for implementing
national nutrition policies to assist Americans in selecting healthy diets.
DESIGN NARRATIVE:
Data from NHANES I and the three cycles of NHANES I Epidemiologic Followup Study (NHEFS)
were used to 1) to examine the associations between several measures of dietary quality at
baseline and subsequent 14-year morbidity and mortality from CVD for a national sample of
6109 United States adults aged 45 to 74 years at baseline; 2) to assess the relative
importance of the associations of dietary quality and CVD for older adults compared to
middle-aged adults. Dietary variables were based on responses to the 24-hour dietary recall
and the food frequency questionnaire administered at baseline and included a composite
measure of dietary quality, intakes of specific nutrients, and usual consumption of foods
from 19 food groups. Baseline measures used as covariates included body mass index, blood
pressure, serum cholesterol, sociodemographic variables (e.g., age, race, income,
occupation), behavioral variables (e.g., smoking, alcohol consumption, activity level), and
chronic health conditions. CVD outcomes were determined from medical history questionnaires,
hospital records and death certificates. Change in blood pressure between baseline and
10-year followup were examined as an outcome variable as well as a covariate in the
association between diet and CVD.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.